Australia Insists Orphan Designations Will Last Only Six Months, Overrides Industry Objections
Sponsors making drugs for rare diseases in Australia who fail to file for approval within six months of being granted orphan designation will see their designation disappear, the Therapeutic Goods Administration has decided. The new procedure will be problematic for orphan drug sponsors and might even make it more difficult for them to use the new expedited pathways the agency is planning to introduce for innovative drugs.
You may also be interested in...
India appears to be on course to developing a national rare disease policy, with the adoption of a specific definition for rare diseases and the initiation of a rare disease registry in the country.
Drugs combining codeine and ibuprofen were among the latest products for which the European Medicines Agency has recommended new risk minimization measures –Imbruvica and terlipressin-containing medicines were the others.
Santhera Pharmaceuticals’ vamorolone for treating Duchenne muscular dystrophy is among the latest medicines that have been submitted for review for potential pan-EU approval.